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NCT Number: NCT00285896

GLP-1 Infusion and Long-Time Fasting

GLP-1 is an incretin hormone that simulates insulin secretion and inhibits glucagon secretion in a glucose dependent way. Below normal plasma glucose levels the effects of GLP-1 stop and the risk of hypoglycemia is small. However no results exits on the effects pharmacologically relevant doses of GLP-1 during long-time fasting. There seems to be a risk of hypoglycemia in healthy people after a fasting period when a glucose load is administered. The risk of hypoglycemia when GLP-1 is administered will be evaluated during these two conditions.

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Key information

Conditions

Type 2 Diabetes Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Fasting Feeding Behavior Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of pharmacology, Aarhus university and Medical department M, Aarhus University hospital

Aarhus, 8000, Denmark

About this study

GLP-1 is an incretin hormone that simulates insulin secretion and inhibits glucagon secretion dependent on a normal plasma glucose.It also inhibits gastric emptying and has a trophic effect on the pancreatic beta-cells. Below normal plasma glucose levels the effects of GLP-1 stop and the risk of hypoglycemia is small.The counter regulatory response to hypoglycemia has been shown to be preserved during GLP-1 infusion. However no results exits on the effects pharmacologically relevant doses of GLP-1 during long-time fasting. There seems to be a risk of hypoglycemia in healthy people after a fasting period when a glucose load is administered. The risk of hypoglycemia when GLP-1 is administered will be evaluated during these two(48 hours of fasting followed by a glucose-load)conditions in healthy men.

Also the effect on 24 hour blood pressure will be evaluated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy male, age 20-50 years, BMI 20-30 kg/m2, Blood pressure < 140/90 mmHg, caucasian.

Exclusion criteria

  • Diabetes in relatives, anaemia, any significant disease, smoking.

Treatment and study plan

Glucagon-like-peptide-1 (7-36) amide

Drug

Continuous, subcutaneous GLP-1 at a dose of 4.8 pmol/kg/min for 51 hours

Other names: GLP-1

Placebo

Drug

continuous subcutaneous placebo infusion at a dose of 4.8 pmol/kg/min for 51 hours

Primary outcomes

  1. Area under curve (AUC)for plasma glucose, insulin, insulin secretion velocity and glucagon for the periods 0-48 hours(day 1-2) and 0-180 min (day 3). And also the lowest plasma glucose during the period 0-180 min day 3 and mean blood pressure

    Time frame: measured every 4 hours for 48 hours (day 1-2) and every 15-30 minutes(day 3)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

The Effect of 48 Hours of GLP-1 Infusion During Long-Time Fasting on Glycaemia and Counterregulatory Hormones

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Feb 2, 2006
Registry last updated
Jul 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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